Hotel Palace, Berlin
44 (0) 20 7368 9836
Agenda Day 1
8:00 am - 8:45 am Registration and welcome coffee
8:45 am - 8:50 am Opening remarks – Sarah Palit, Content Director, WBR
8:50 am - 8:55 am Chair’s opening address and networking activity
8:55 am - 9:00 am Around the World Charity Competition Icebreaker
9:00 am - 9:20 am KEYNOTE ADDRESS: Electronic health record (EHR) to EDC: How can you collaborate and remove barriers with investigator sites to enable a multi-centric trial data collection capability?Nadir Ammour - DDS, MBA, Innovation Domain Leader, Patients and Sites, Sanofi R&D/Clinical Science & Operations Sanofi R&D
· What are the key challenges to using EHR data to EDC throughout all clinical trials sites and how can this be overcome?
· How can you make EHR data from multiple clinical sites transferable to a study EDC system data is compliant with regulations?
· What are the best strategies to optimize the value of in re-using EHR data to populate an EDC ?
· How can reducing time on eCRF data entry improve productivity and focus on strategic goals?
Nadir AmmourDDS, MBA, Innovation Domain Leader, Patients and Sites, Sanofi R&D/Clinical Science & Operations
9:20 am - 9:40 am How to take advantage of the opportunities for Blockchain Technology in Clinical Trials: A high level view
- How to use Distributed Ledger Technology as a catalyst for digital transformation
- How can you liberate patient data from data silos to transform the clinical trials space?
- How to understand the potential impact of distributed data on the healthcare industry
9:40 am - 10:20 am ALL STAR PANEL How to gain value from blockchain technology in your Clinical Trials – where are the opportunities in patient data, how can you overcome compliance challenges and what pitfalls should you avoid?Pasi Piitulainen - Head of Global R&D Procurement Actelion Pharmaceuticals Mehdi Benchoufi - Assistant Professor Centre d’Epidémiologie Clinique, APHP, Université Paris Descartes-Sorbonne Paris Cité
10:20 am - 11:00 am Networking Break
11:00 am - 11:20 am Our story: How to develop an innovative, risk-sharing strategic partnership with your central lab to save significant costs and reduce your trial timeCatherine Mela - Head of Clinical Sample and Bioanalytical Sciences AstraZeneca Estelle Natali - Strategic Alliance Leader Covance Central Laboratory Services
- How to successfully integrate the central lab team within your team
- How can you review assay, bioanalysis, specialty labs services to make overall cost savings
- How to negotiate with your supplier to encourage them to share risk on committing to new studies
- What are the main lessons-learned and what would be done differently next time?
Estelle NataliStrategic Alliance Leader
Covance Central Laboratory Services
Driving Digital Innovation
11:20 am - 11:40 am Revolutionizing Clinical Development: What will digitalisation, data science and artificial intelligence do to drug development - and what should you change to benefit the most?Marc Philipp - Partner/ Managing Director - Accenture Strategy, Life Sciences Accenture
- Understanding the impact and value of digitalisation on pharma R&D
- How to implement the trials of the future: Stronger patient engagement and better outcomes
- How to get the best out of insight-driven development operating models
- What are the strategic imperatives for Clinical Operations?
Marc PhilippPartner/ Managing Director - Accenture Strategy, Life Sciences
11:40 am - 12:20 pm ALL STAR PANEL Virtual clinical trials: How can you scale-up and overcome challenges in your remote and virtual clinical trials to improve patient recruitment and retention?Michelle Longmire - Co-founder & CEO Medable Catherine Mela - Head of Clinical Sample and Bioanalytical Sciences AstraZeneca
· How can you roll our virtual trials effectively to improve patient recruitment and retention?
· How can remote trials help to recruit hard-to-reach patients?
· How to build patient compliance with digital and remote evidence to reduce the amount of investigator-patient contact
· How can you involve and gain buy-in from smaller investigator sites in remote and virtual trials?
- How can you ensure patients and investigators are appropriately trained to use a new technology within time and cost constraints
Michelle LongmireCo-founder & CEO
12:20 pm - 1:30 pm Networking lunch
12:20 pm - 1:30 pm MASTERCLASS/WORKSHOP
TRACK A – Transforming Partnerships and eClinical Tools1:40 pm - 2:45 pm CASE STUDY ROUNDTABLES How to choose and work with the right CROs and vendors for your trials in terms of size, regional remit and expertise to reduce failure and unnecessary costs? Paul Bouten - Founder PharmCMed Gareth Crowder - Senior Global Category Manager Norgine Sabine Pilot - Head of Clinical Operations Santhera
Listen to an inspiring case study on how you can select and implement new ways of working with the right CROs and vendors, and then join your peers in roundtables focused on large, mid-size and small pharma to discuss the specific challenges you are facing to reduce trial failures and reduce costs.
· How can you ensure the tender and RFP process works effectively to work with different and smaller vendors?
· What are the best strategies to source and procure the correct vendor or CRO for your trials?
· How can large CROs best work with a pharma/biotech company of your size?
· How can you develop a more flexible relationship with your CROs in order to ensure that you are getting the best service and deal?
Case study leader: Paul Bouten, Founder, PharmCMed
TABLE 1 – Large Pharma Dr Raphaele Mary, former Director Capability & Strategy, Global Procurement, Global Clinical Operations, Bristol-Myers Squibb
TABLE 2 – Mid-Size Pharma – Gareth Crowder, Head of Global Category Management - Development, Norgine
TABLE 3 – Small Pharma/Biotech Sabine Pilot, Head of Clinical Operations, Santhera
Gareth CrowderSenior Global Category Manager
Sabine PilotHead of Clinical Operations
2:45 pm - 2:50 pm 5 minutes transit time
2:40 pm - 3:00 pm INNOVATION IN CLINICAL TRIALS TECH SPOTLIGHT SESSIONS AND Q&AEytan Oppenheim - International Business Development Synektik S.A. Michelle Longmire - Co-founder & CEO Medable
10 mins: Mobile apps in clinical trials
Michelle Longmire, Co-founder & CEO, Medable
10 mins: How can you best use cyclotron produced PET tracers in your Clinical Trials to reduce trial time and increase trial quality? Eytan Oppenheim, International Business Development, Synektik S.A.
· How can you overcome objections from partners to implementing technology across your clinical trials?
· What skills do you and your team need to develop to work with new technology across trials?
· How can you identify and reduce the risks involved with innovation?
· What are the areas where technology can be implemented for the highest ROI?
10 mins: Q&A
Eytan OppenheimInternational Business Development
Michelle LongmireCo-founder & CEO
3:00 pm - 3:40 pm Networking break
3:40 pm - 4:00 pm How can you use AI to improve your patient recruitment strategy?Jean-David Zeitoun - Chief Medical Officer and Co-Founder Inato
20 minute presentation - 15 mins talk – 5 mins questions from audience
Jean-David ZeitounChief Medical Officer and Co-Founder